Atopalm Oral Pain Relief
FDA Label NDC 51141-0236

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm, Usa for the product Atopalm Oral Pain Relief (NDC 51141-0236). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 10%

Purpose

Oral Pain Reliever

Use

for the temporary relief of pain due to toothaches.

Warnings

Allergy alert:

  • do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

Do Not Use

  • more than directed
  • for more than 7 days unless told to do so by a dentist or a doctor.

Stop Use And Ask A Doctor If

  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • cut open tip of tube at score mark
    • Adults and children 2 years of age and older
    • apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or a doctor.
      • Children under 12 years of age
      • should be supervised in the use of this product.
        • Children under 2 years of age
        • ask a dentist or a doctor.

Other Information

  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

Inactive Ingredients

PEG-400, PEG-6000, Glycerin, Sodium Saccharin, Sorbic Acid, Flavor

Questions Or Information?

Call toll free 1-855 ATOPALM – (1-855-286-7256)

Labeling Information

ATOPALM Oral Pain Relief Gel

Fast Temporary Relief of Pain Due to Toothache

Benzocaine 10%


Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760
Made in Korea




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